FACTOR II (PROTHROMBIN) G20210A KIT— 510(k) K033612

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K033612 for FACTOR II (PROTHROMBIN) G20210A KIT, Substantially Equivalent on 2003-12-18. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code NPR
Advisory panel: Hematology
Date received: 2003-11-17
Decision date: 2003-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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